TEL AVIV - BioLineRx Ltd. (NASDAQ: BLRX), a biopharmaceutical company, announced encouraging results from the pilot phase of its CheMo4METPANC Phase 2 clinical trial in pancreatic cancer. The study, which includes the company's CXCR4 inhibitor motixafortide, showed an increase in CD8+ T-cell density in tumors and a higher disease control rate compared to standard therapies.
The trial, sponsored by Columbia University, is evaluating motixafortide combined with the PD-1 inhibitor cemiplimab and chemotherapies gemcitabine and nab-paclitaxel, against the chemotherapies alone. Updated results from the pilot phase indicated that all 11 patients treated with the combination therapy experienced an increase in CD8+ T-cell density in their tumors.
As of February 6, 2024, 64% achieved a partial response, with 91% showing disease control. This compares favorably to historical rates of 23% for partial response and 48% for disease control with gemcitabine and nab-paclitaxel alone. The preliminary median progression-free survival was 9.6 months, versus 5.5 months historically.
Philip Serlin, CEO of BioLineRx, emphasized the significance of these findings, noting the increased immune cell activation and potential for a new therapeutic option for pancreatic cancer. Following these results, the trial has been expanded to a randomized study with a target enrollment of 108 patients.
Pancreatic cancer is known for its low early diagnosis rate and poor prognosis. In the United States, it represents about 3% of all cancers and 7% of all cancer deaths, with a 5-year relative survival rate of 3% for metastatic cases.
Motixafortide, BioLineRx's first approved product, is also indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. The company is advancing a pipeline of investigational medicines for various cancers and rare diseases.
The findings from the CheMo4METPANC Phase 2 trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on Saturday, June 1, 2024, in Chicago, Illinois.
This news is based on a press release statement from BioLineRx Ltd.
InvestingPro Insights
As BioLineRx Ltd. (NASDAQ: BLRX) shares news of promising trial results for its pancreatic cancer treatment, investors and analysts are closely monitoring the company's financial health and market performance. Here are some key metrics and insights from InvestingPro that could be relevant for stakeholders:
Despite the clinical progress, BioLineRx's financial situation presents challenges. The company is not profitable over the last twelve months as of Q1 2023, with an adjusted operating income of approximately -$42.99M USD, reflecting significant operating costs. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year. The company's P/E Ratio stands at -0.96, suggesting that the market has concerns about its future earnings potential.
On a more positive note, another InvestingPro Tip reveals that BioLineRx holds more cash than debt on its balance sheet, which could provide some financial stability as it continues to fund its research and development activities. However, it is worth noting that the company is quickly burning through cash, which is a critical factor for investors to consider.
The stock is currently trading near its 52-week low, with the price at the previous close being $0.61 USD. The company's market capitalization is relatively small at 52.48M USD, which often implies higher volatility and risk for investors. BioLineRx does not pay a dividend, which may deter income-focused investors but could be a prudent decision to conserve cash for its operational needs.
For those interested in a deeper analysis, InvestingPro offers additional insights and metrics. Utilize coupon code PRONEWS24 to get an extra 10% off a yearly or biyearly Pro and Pro+ subscription, and access more InvestingPro Tips to inform your investment decisions. Currently, there are 9 additional tips available for BioLineRx on InvestingPro, providing a comprehensive overview of the company's financial health and market performance.
The upcoming ASCO Annual Meeting presentation could be a pivotal moment for BioLineRx, potentially impacting both the company's clinical trajectory and its stock valuation. Investors may wish to keep a close eye on these developments as they unfold.
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